Apparatus and method for use of an inclinometer-aided needle guide

ABSTRACT

A system, method, and apparatus for guiding a needle into a target location of a patient&#39;s body are provided. The system includes a planned needle guide trajectory and a guide for removable attachment to a smartphone. The guide includes at least one needle guiding aperture extending substantially perpendicularly to a screen of the smartphone. The needle guiding aperture defines an actual needle guide trajectory. An inclinometer application is running on the smartphone. The inclinometer application indicates to a user conformance of the actual needle guide trajectory to the planned needle guide trajectory.

RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No.15/967,358, filed 30 Apr. 2018, which claims priority from U.S.Provisional Application No. 62/492,628, filed 5 Jan. 2017, the subjectmatter of both of which is incorporated herein by reference in itsentirety.

TECHNICAL FIELD

This disclosure relates to an apparatus and method for use of aninclinometer-aided needle guide and, more specifically, to a smartphoneattachment and corresponding software to assist a medical professionalwith guiding a needle into a patient's body along a predeterminedtrajectory.

BACKGROUND

Cross-sectional imaging for guiding percutaneous procedures in the humanbody is known. Such procedures, which may include Computed Tomography(CT), Magnetic Resonance Imaging (MRI), Ultrasound, any other suitableimaging technique(s), or any combination thereof, use directvisualization to determine a safe needle path that hopefully avoidsarteries, veins, nerves, bowel, etc. These known procedures include aplanning phase in which scout images are obtained to identify a targetsuch as a lesion. Next, as part of the planning phase, a safe path tothe lesion is determined including identification of a skin entrancesite. The length of the needle required to reach the target along theselected path is determined. After this planning phase, the procedure iscarried out. As part of the procedure, the needle is inserted into theskin at an approximate angle determined during the planning phase butonly to a minimal or shallow depth. The patient is then moved into anexamination gantry of an imaging device such as CT scanner. While in thescanner, images are obtained that identify the actual position of theneedle relative to the target and the planned path. The patient is thenpulled out from the scanner and the needle is repositioned and inserteddeeper. This process is repeated until the target is reached.

SUMMARY

In an aspect, a system for guiding a needle into a target location of apatient's body is provided. The system includes a planned needle guidetrajectory and a guide for removable attachment to a smartphone. Theguide includes at least one needle guiding aperture extendingsubstantially perpendicularly to a screen of the smartphone. The needleguiding aperture defines an actual needle guide trajectory. Aninclinometer application is running on the smartphone. The inclinometerapplication indicates to a user conformance of the actual needle guidetrajectory to the planned needle guide trajectory.

In an aspect, an apparatus for assisting an inclinometer in guiding aneedle into a target location of a patient's body is provided. Theapparatus includes a top guide surface and a bottom guide surface,longitudinally spaced from the top guide surface by a guide body. Aninclinometer-accepting slot extends laterally into the guide body and islongitudinally spaced from both the top and bottom guide surfaces. Atleast one handle extends longitudinally upward from the top guidesurface. At least one needle guiding aperture extends through the guidebody substantially perpendicularly to the top and bottom guide surfacesand selectively accepts at least a portion of the needle longitudinallytherethrough.

In an aspect, a method for guiding a needle into a target location of apatient's body is provided. A planned needle guide trajectory isprovided. An inclinometer with a removably attached guide is provided.The guide includes at least one needle guiding aperture extendingsubstantially perpendicularly to a display of the inclinometer. With theneedle guiding aperture, an actual needle guide trajectory is defined. Aneedle is inserted at least partially into the needle guiding aperturesubstantially parallel to the actual needle guide trajectory. Theinclinometer is maintained in a predetermined orientation with respectto the patient's body. The predetermined orientation is responsive tothe planned needle guide trajectory. With the inclinometer maintained inthe predetermined orientation with respect to the patient's body, theneedle is advanced at least partially through the needle guidingaperture and into the patient's body. With the inclinometer, the actualneedle guide trajectory is monitored during advancement of the needle.Conformance of the actual needle guide trajectory to the planned needleguide trajectory is indicated to a user.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding, reference may be made to the accompanyingdrawings, in which:

FIG. 1 is a perspective top view of an aspect of the present invention;

FIG. 2 is a side view of the aspect of FIG. 1 ;

FIG. 3 is a top view of the aspect of FIG. 1 in an example useenvironment;

FIG. 4A is an exploded schematic side view of an example configurationof the aspect of FIG. 1 ;

FIG. 4B is an assembled view corresponding to FIG. 4A;

FIG. 5A is an exploded schematic side view of an example configurationof the aspect of FIG. 1 ;

FIG. 5B is an assembled view corresponding to FIG. 5A;

FIG. 6 is a perspective top view of the aspect of FIG. 1 having analternate detail configuration;

FIGS. 7-8 depict an example sequence of use of the aspect of FIG. 5 ;

FIG. 9 is a schematic top view of the aspect of FIG. 1 including analternate detail configuration;

FIG. 10 is a schematic top view of the aspect of FIG. 1 in an exampleconfiguration;

FIG. 11 is a schematic side view of the aspect of FIG. 9 ;

FIGS. 12-14 are schematic side views of example configurations of theaspect of FIG. 1 ;

FIGS. 15-17 depict a portion of an example sequence of use of the aspectof FIG. 1 ;

FIGS. 18-19 are top views of alternate configurations of an accessoryitem for the aspect of FIG. 1 ;

FIGS. 20-24 depict a portion of an example sequence of use of the aspectof FIG. 1 ;

FIGS. 25-29 depict a portion of an example sequence of use of the aspectof FIG. 1 ; and

FIGS. 30-35 depict an example sequence of use of the aspect of FIG. 1 .

DESCRIPTION OF ASPECTS OF THE DISCLOSURE

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as is commonly understood by one of skill in theart to which the present disclosure pertains.

As used herein, the term “subject” can be used interchangeably with theterm “patient” and refer to any warm-blooded organism including, but notlimited to, human beings, pigs, rats, mice, dogs, goats, sheep, horses,monkeys, apes, rabbits, cattle, farm animals, livestock, etc.

As used herein, the singular forms “a,” “an” and “the” can include theplural forms as well, unless the context clearly indicates otherwise. Itwill be further understood that the terms “comprises” and/or“comprising,” as used herein, can specify the presence of statedfeatures, steps, operations, elements, and/or components, but do notpreclude the presence or addition of one or more other features, steps,operations, elements, components, and/or groups thereof.

As used herein, the term “and/or” can include any and all combinationsof one or more of the associated listed items.

It will be understood that when an element is referred to as being “on,”“attached” to, “connected” to, “coupled” with, “contacting,” etc.,another element, it can be directly on, attached to, connected to,coupled with or contacting the other element or intervening elements mayalso be present. In contrast, when an element is referred to as being,for example, “directly on,” “directly attached” to, “directly connected”to, “directly coupled” with or “directly contacting” another element,there are no intervening elements present. It will also be appreciatedby those of skill in the art that references to a structure or featurethat is disposed “directly adjacent” another feature may have portionsthat overlap or underlie the adjacent feature, whereas a structure orfeature that is disposed “adjacent” another feature might not haveportions that overlap or underlie the adjacent feature.

Spatially relative terms, such as “under,” “below,” “lower,” “over,”“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms can encompass different orientations of adevice in use or operation, in addition to the orientation depicted inthe figures. For example, if a device in the figures is inverted,elements described as “under” or “beneath” other elements or featureswould then be oriented “over” the other elements or features.

It will be understood that, although the terms “first,” “second,” etc.may be used herein to describe various elements, these elements shouldnot be limited by these terms. These terms are only used to distinguishone element from another. Thus, a “first” element discussed below couldalso be termed a “second” element without departing from the teachingsof the present disclosure. The sequence of operations (or steps) is notlimited to the order presented in the claims or figures unlessspecifically indicated otherwise.

The invention comprises, consists of, or consists essentially of thefollowing features, in any combination.

FIG. 1 depicts an apparatus 100 for assisting an inclinometer in guidinga needle into a target location of a patient's body. The apparatus 100includes a top guide surface 102 and a bottom guide surface 104,longitudinally spaced from the top guide surface 102 by a guide body106. The “longitudinal” direction, as referenced herein, issubstantially parallel to the vertical direction up and down along thepage, in the orientation of FIG. 2 . An inclinometer-accepting slot 116extends laterally into the guide body 106 and is longitudinally spacedfrom both the top and bottom guide surfaces 102 and 104. As referencedherein, the “lateral” plane is orthogonal to the longitudinal direction,and is substantially perpendicular to the plane of the page into and outof FIG. 2 .

As shown in at least FIGS. 1-3 , the guide body 106 may include agrasping segment 108 having laterally spaced first and second graspingsegment ends 110 and 112. The grasping segment 108 may be longitudinallybounded by the top and bottom guide surfaces 102 and 104. A side arm 114may extend orthogonally and laterally from a selected one of the firstand second grasping segment ends 110 and 112. The side arm 114 may be afirst side arm 114 a. The guide body 106 may include a second side arm114 b extending orthogonally and laterally from an other one of thefirst and second grasping segment ends 110 and 112. When present, thefirst and second side arms 114 a and 114 b may both extend in the samedirection from the grasping segment 108, such as to form the “C” shapedconstruct shown in the Figures. The first and second side arms 114 a and114 b, when provided, may each be of any desired dimensions and relativelengths for a particular use environment of the present invention. It iscontemplated, though, that the first and second side arms 114 a and 114b may be configured to assist with holding a particular type ofinclinometer. A range of apparatuses 100, each configured to “match” orbe used with a particular inclinometer model (such as, but not limitedto, including specifically configured first and second side arms 114 aand 114 b), may be provided.

The inclinometer 318 shown in the Figures for the sake of description isa smartphone running an inclinometer software application. However, itis contemplated that any suitable digital and/or analog inclinometer,such as, but not limited to, a bubble level or a single-functionelectronic inclinometer, may be used with an appropriately configuredapparatus 100.

The inclinometer-accepting slot 116 may be configured to concurrentlylie adjacent to and/or contact at least three adjoining orthogonal sidesof the inclinometer 318, as shown in the example use view of FIG. 3 .The inclinometer-accepting slot 116 may extend completely laterallythrough the guide body 106, such that the apparatus 100 slides entirelyonto and around the inclinometer 318, or may instead be a “blind”aperture which limits the extent to which the inclinometer 318 can beinserted into the apparatus 100.

A simple inclinometer-accepting slot 116, such as the rectangular slotof FIGS. 1-3 could be sized to slide relatively smoothly with respect tothe inclinometer 318, or could hold the inclinometer 318 in a frictionalor interference fit. As shown in the example of FIGS. 4A-4B, the guidebody 106 could include an at least partially “spring clip” typeinclinometer-accepting slot 116, which “clips” or “clamps” onto at leasta portion of the inclinometer 318 under elastic deformation. Anotherexample inclinometer-accepting slot 116 is shown in FIGS. 5A-5B andincludes a “vice-type” structure which has a longitudinally varyingopening and a mechanism which allows the jaws thereof to move into“open” and “closed” positions (e.g., via a rack-and-pinion structure orin any other manner) to “bite” down on the inclinometer 318 in lieu ofthe lateral sliding motion used in the other inclinometer-acceptingslots 116 shown herein. However, one of ordinary skill in the art willbe able to associate the apparatus 100 with an inclinometer 318 asdesired, with any desired amount (or none) of “gripping” of theinclinometer 318, for a particular use environment of the presentinvention.

With reference back to FIG. 1 , at least one handle 120 (two shown) mayextend longitudinally upward from the top guide surface 102. Thehandle(s) 120 may have any desired configuration, including, but notlimited to, the depicted simple rectangular “fin” type, an ergonomicallycurved construct, or any other desired type of handle 120 operative toassist a user with holding the apparatus 100. During operation of theapparatus 100, the user can hold the handles 120 in the “pincher” typegrip shown in FIG. 3 . The handles 120 may assist with achieving desiredcontrol over motion of the apparatus 100, particularly when aninclinometer 318 is being supported or held by the apparatus 100.

At least one needle guiding aperture 122 may extend through the guidebody 106 substantially perpendicularly to the top and bottom guidesurfaces 102 and 104, as shown in at least FIG. 1 . The needle guidingaperture 122 may selectively accept at least a portion of the needlelongitudinally therethrough, as will be discussed further below. The atleast one needle guiding aperture 122 may extend through a portion ofthe guide body 106 forming a side arm 114, for example, particularly ifsuch might be helpful in avoiding unwanted contact between the needleand the inclinometer 318.

As shown in FIG. 1 , the at least one needle guiding aperture 122 may beone of a plurality of needle guiding apertures 122. Each needle guidingaperture 122 may have a different largest cross-sectional dimension(e.g., a diameter when the needle guiding aperture 122 is a round hole),measured laterally, than the other needle guiding apertures 122. Eachneedle guiding aperture 122 may also or instead have any other physicaldifference from at least one other needle guiding aperture 122, otherthan its position on the apparatus 100. As a result, a plurality ofneedle guiding apertures 122 can be provided, with each one suited for adifferent guiding task (e.g., for guiding a different size needle).

As shown in FIGS. 6-8 , the at least one needle guiding aperture 122 maybe a longitudinally extending slot, providing laterally oriented accessfor the needle thereinto. For example, and as shown in FIGS. 7-8 , aneedle 724 could be placed laterally beside the apparatus 100, and thenthe needle 724 and apparatus 100 could be moved laterally relative toone another until the needle 724 extends substantially longitudinallybetween the top and bottom guide surfaces 102 through the slot-typeneedle guiding aperture 122, as shown in FIGS. 6-8 . This slot-typeneedle guiding aperture 122 may be helpful when longitudinal movement ofthe needle 724 is constrained, such as, for example, if a lower end ofthe needle 724 is already penetrating into the patient's tissue belowthe apparatus 100. For the sake of determination of the “largestcross-sectional dimension” for a slot-type needle guiding aperture 122,the open side or “mouth” of the slot (through which the needle 724enters) could be considered to be bounded by a plane substantiallyparallel to the local longitudinally extending portion of the guide body106 adjacent to the “mouth” of the slot.

FIG. 9 schematically illustrates another example option of aconfiguration of a needle guiding aperture 122, wherein a jaw portion926 moves relative to the guide body 106, such as in the substantiallyparallel motion provided by the guide tracks 928 attaching the jawportion 926 to the guide body 106. In the configuration shown in FIG. 9, the needle guiding aperture 122 comprises a pair of notches 930 in thejaw portion 926 and guide body 106. These notches 930 move laterallywith respect to each other, via relative lateral motion of the jawportion 926 and the guide body 106 to accommodate any of a variety ofneedle 724 sizes.

With reference now to FIGS. 10-11 , an anesthesia port 1032 may extendobliquely through a portion of the guide body 106 and be in fluidcommunication with the at least one needle guiding aperture 122 at thebottom guide surface 104. Through use of the anesthesia port 1032, ananesthetic syringe 1034 could penetrate into the guide body 106 and beused to inject a local anesthetic into the patient tissue at or near anintersection of the needle guiding aperture 122 with the patienttissue—i.e., the location where the needle 724 will be penetrating intothe patient tissue under guidance from the apparatus 100.

A device leveler 1236 may extend longitudinally downward from the guidebody 106, below the bottom guide surface 104. When present, the deviceleveler 1236 may be used to help maintain a desired orientation of theinclinometer 318 in space relative to the patient tissue 1238,regardless of the local contours of that patient tissue 1238. The deviceleveler 1236, when present, may have any suitable form. For example, amalleable “beanbag” type device leveler 1236 is shown in FIG. 12 , withthe device leveler 1236 including a gel pad or other structure whichfacilitates contact between a relatively large, varying-profile surfaceof the device leveler 1236 and the patient tissue 1238. Another exampledevice leveler 1236′ is shown in FIG. 13 . Here, instead of the somewhatplanar, surface contact shown in FIG. 12 , a plurality of bendable ormalleable device legs 1340′ each makes point contact with the patienttissue 1238. The device legs 1340′ can be bent by the user as desired tohelp achieve and maintain a desired “leveling”, or other orientation ofthe inclinometer 318 with respect patient service 1238. Like the deviceleveler 1236′ of FIG. 13 , the device leveler 1236″ of FIG. 14 includesa plurality of device legs 1340″ which each makes point contact with thepatient tissue 1238. However, the device legs 1340″ of FIG. 15 eachinclude a telescoping configuration, to allow for the longitudinaldimension of each device leg 1340″ to be changed and then maintained ata desired length (optionally with the aid of a set screw or frictionalfit within the telescoping). Regardless of the nature of any deviceleveler 1236 provided (whether depicted or not herein), one of ordinaryskill in the art can achieve a desired orientation of the inclinometer318 with respect to the patient tissue 1238 with a device leveler 1236configured for particular use environment.

The sequence of FIGS. 15-17 show how a user can move the apparatus 100,with an associated inclinometer 318, to achieve a desired trajectory ofthe needle guiding aperture 122 of the apparatus 100 with respect to anunderlying patient tissue 1238 surface. In FIG. 15 , the inclinometer318 is associated with the apparatus 100 and the user grasps the handles120 to at least partially lift the inclinometer 318 from the patienttissue 1238. As shown in FIG. 16 , a target indicator 1642 of theinclinometer 318 is shown as being off-center from a desired targetlocation. Here the target indicator 1642 is a red dot and the desiredtarget location is represented by the center of a “crosshairs” graphic.The desired target location is graphically depicted by the inclinometer318 (which may comprise a smartphone) responsive to the “knowledge” bythe inclinometer 318 of the planned trajectory of the needle guidingaperture 122 of the apparatus 100. That planned needle guide trajectoryis stored in a computer-readable media readable by theinclinometer/smartphone. When the target indicator 1642 is “on target”to the crosshairs, the needle guiding aperture 122 can be considered tohave achieved a desired trajectory with respect to an underlying patienttissue 1238 (i.e., the planned needle guide trajectory). However, it iscontemplated that any desired technique may be used to indicate to auser whether the needle guiding aperture 122 is in position as desired,and/or a direction, magnitude, or any other property of motion whichwould be appropriate to move the needle guiding aperture 122 toward thepredetermined desired trajectory, as discussed further below. The targetindicator 1642 can include, or be a part of, any desireduser-perceptible indicating scheme, such as, but not limited to, anaudible signal, a numerical signal, a graphical representation of one ormore arrows, a graphical representation of a bull's-eye or crosshairs,any other graphical signal or representation, a haptic indication, orany other desired user-perceptible indicator or combination thereof.

The user then can manipulate the apparatus 100, with the associatedinclinometer 318, as shown in FIG. 17 to “shift” the target indicator1642 toward a desired position. For example, as shown in FIG. 17 , theapparatus 100 has been manipulated to move the target indicator 1642substantially into the vertical center of the screen (in the orientationof FIG. 17 ), but further motion would be appropriate to shift thetarget indicator 1642 toward the horizontal center of the screen (in theorientation of FIG. 17 ). Thus, the apparatus 100 and inclinometer 318can be used in almost a “joystick” type manner to shift or precess thetrajectory of the needle guiding aperture 122 with respect to anunderlying patient tissue 1238 surface, at a known desired needle 724site on the patient tissue 1238 surface.

With reference now to FIGS. 18-24 , the inclinometer 318 may include anoptical sensor 2444, such as a camera when the inclinometer 318 isassociated with a smart phone, as in the Figures. The apparatus 100 willthen include, and/or be used with, a contrast indicator 1846 forselective engagement with the needle 724. The contrast indicator 1846may be detectable with the optical sensor 2444 for assisting withguiding the needle 724 into the target location on the patient tissue1238, and at a desired trajectory and insertion depth. FIGS. 18-19depict two different example configurations of a suitable contrastindicator 1846. Also contemplated, though not shown in FIGS. 18-19 , isa “bead” or spherical contrast indicator. The sequence of FIGS. 20-23show the contrast indicator 1846 being placed on 2007 24, and slid upthe needle 724, with the “indicating” side of the contrast indicator1846 (i.e., a surface including some sort of indicia perceptible by theoptical sensor 2444) facing downward, toward the inclinometer 318.

FIG. 24 depicts how the optical sensor 2444 can be used to calculatedistance traveled by the needle 724 using the apparent size of thecontrast indicator 1846, with specific use of the formula slope(m)=(y2−y1)/(x2−x1). (The apparatus 100 shown in FIG. 24 differsslightly in configuration from other apparatuses 100 shown graphically,in order to simplify the below discussion, but one of ordinary skill inthe art can readily configure a suitable apparatus 100 for a particularuse environment.) In this case, relating an apparent change in diameterof the bead-type contrast indicator 1846 between a first insertionposition x1 and a second, deeper/later insertion position x2 will helpthe user and/or the inclinometer 318 calculate the change in needledistance traveled between those two positions (y2−y1). A calibrationprocedure of any desired type may occur, such as, but not limited to,measurement of the change of apparent contrast indicator 1846 size dueto needle 724 travel over a known longitudinal distance relative to theoptical sensor 2444. The contrast indicator 1846 (and its change inapparent size) could be displayed to the user, in some use environmentsof the apparatus 100.

In order to use this formula, the apparent size of the contrastindicator 1846 can be determined using the camera and image processingto determine the maximum dimension (e.g., diameter) of at least aportion of the contrast indicator 1846 as measured in pixels, given aknown insertion depth (e.g., an insertion depth of zero, with thedistalmost end of the needle 724 just touching the patient tissue 1238surface). The position of the contrast indictor 1846 with respect to theoptical sensor 2444 is also known, by virtue of its attachment to theneedle 724.

The contrast indicator 1846 can then be moved to a point closer to theoptical sensor 2444 via insertion of the needle 724 into the patienttissue 1238. The contrast indicator 1846 size in terms of pixels asabove is measured.

The change in distance of the contrast indicator 1846 from the opticalsensor 2444=(y2−y1)

The change in contrast indicator 1846 size in pixels=(x2−x1)

The linear equation describing this relationship is Δy=mΔx

This formula can be used in practice by setting the needle 724 insertiondepth to zero, or any other desired initial value, by setting a “tare”on the inclinometer software application or in any other desired manner.The pixel size of the contrast indicator 1846 is noted at this “zeroed”position. As the needle 724 is inserted into the patient tissue 1238 andthe contrast indicator 1846 comes closer to the optical sensor 2444, theapplication continuously determines the size of the contrast indicator1846 in terms of pixels (image processing), compares it to the originalzero position contrast indicator 1846 size to determine Δx (in acontinuous or step-measure-step type manner) and from these valuescalculates the change in needle 724 insertion depth/distance Δy. Δy isthen displayed on the screen as desired to provide feedback to the useron the needle 724 insertion distance. There could also be visual,audible, haptic, and/or any other user-perceptible feedback when theneedle 724 is closely approaching, or has reached, a predetermined depthof insertion.

FIGS. 25-29 depict a manner in which a depth of needle 724 insertioninto the patient tissue 1238 can be indicated and/or controlled. FIGS.25-27 show a scale or ruler 2548 which can be used to help prepare aneedle 724 for a depth-controlled and/or depth-monitored insertion intothe patient tissue 1238. In FIG. 25 , the apparatus 100 is beingcompared against the ruler 2548 so that the thickness of the apparatus100, between the top and bottom guide surfaces 102 and 104, can be takeninto account during needle depth measurements. A “tare zone” 2550 isthen blocked off, and the ruler 2548 is shifted over (here, toward theright of FIG. 25 ) so that the insertion depth is not undesirably offsetby the thickness of the guide body 106. In FIG. 26 , the needle 724 isplaced into alignment with the ruler, with a distal tip of the needleextending across the tare zone 2550 so that the origin of the ruler 2548is displaced from the distalmost end of the needle 724 by the thicknessof the guide body 106. The user then locates, on the ruler 2548, adesired insertion depth for the needle 724 into the patient tissue 1238.In the example of these Figures, an insertion depth of 7 cm isindicated.

With reference now to FIG. 27 , a marking device 2752 is used to two-and/or three-dimensionally alter the needle 724 at the desired insertiondepth as indicated on the ruler 2548. (Again, this insertion depth isoffset from the distalmost end of the needle 724 but thickness of theguide body 106, so the alteration or marking will actually occurslightly more than 7 cm from the distalmost end of the needle 724, inthis example.) Any desired user-perceptible marking scheme could beprovided, such as, but not limited to, an ink marking on the needlebody, a crimped collar 2854 around the needle body, any other desiredmarking technique, or any other combination thereof.

In FIG. 28 , the needle 724 has been inserted into the needle guidingaperture 122, and the needle 724 is being moved downward, into theunderlying patient tissue 1238 surface. In FIG. 29 , the crimped collar2854 has come into contact with the top guide surface 102. Here, sincethe crimped collar 2854 has a larger diameter than the needle guidingaperture 122, the crimped collar 2854 will help to prevent furtherinsertion of the needle 724 once the desired insertion depth has beenachieved. It is contemplated, however, that even a two-dimensionalmarking (e.g., an ink or paint mark) can assist a user with avoidingoverinsertion of the needle 724 into the patient tissue 1238.

FIGS. 30-35 depict a method for guiding a needle 724 into a targetlocation of a patient's body, using a system including an apparatus 100as described above.

The system as shown and described herein includes a planned needle guidetrajectory. That is, the user, as a starting point, has informationpertaining to an insertion location for the needle 724 into the patienttissue 1238, as well as a desired planned needle guide trajectory totake the needle 724 from that insertion location to a desired targetsite within the patient tissue 1238 (e.g., to a subcutaneous cyst, seedinsertion site, biopsy location, or for any other desired subcutaneousneedle-assisted task or combination thereof). The user will also know adesired insertion depth for the needle 724 at that insertion locationand along that planned needle guide trajectory. This information cancome from any suitable source, including, but not limited to,preoperative imaging of the patient tissue 1238 and can be stored in acomputer-readable media readable by the smartphone 318 or otherelectronic inclinometer, for retrieval and comparison as disclosedherein. One of ordinary skill in the art can readily generate such“orientation” or “targeting” information for a particular useenvironment.

The apparatus 100 as shown in FIGS. 30-35 is a guide 100 for removableattachment to a smartphone, such as a smart phone 318 running aninclinometer software application, as depicted. The guide 100 includesat least one needle guiding aperture 122 extending substantiallyperpendicularly to a screen of the smartphone 318. The needle guidingaperture 122 defines an actual needle guide trajectory—i.e., a linealong which the needle 724 is actually extending when inserted into theneedle guiding aperture 122. It is contemplated that a plurality ofneedle guiding apertures 122 may be provided on a single guide 100, andone of ordinary skill in the art can then choose, potentially with theassistance of a surgical guide (e.g., planning software), the specificneedle guiding aperture 122 into which the needle 724 is to be inserted.For example, the user can select the smallest needle guiding aperture122 within which the needle 724 can still move freely longitudinally.

As previously mentioned, an inclinometer application may be running onthe smartphone 318 acting as inclinometer. The inclinometer application(on the smartphone) can indicate to a user conformance of the actualneedle guide trajectory to the planned needle guide trajectory as storedin the computer-readable media readable by the smartphone 318.

Because the user knows the actual needle guide trajectory, the plannedneedle guide trajectory, and the desired insertion location, theapparatus 100 can be used to help guide the needle 724 into a desireddepth, trajectory, and location of insertion into the patient tissue1238, toward a desired target site. The planned needle guide trajectorycould be relative to a local (e.g., on the patient, such as withreference to a known patient marker device) and/or global (e.g., withrespect to the operating room as a whole and/or to the Earth) frame ofreference. The below description presumes that the inclinometer measuresthe actual needle guide trajectory with respect to the Earth, such as byusing accelerometers provided in the smartphone 318.

In FIG. 30 , a sterile cover 3056 may be provided for selectiveengagement with the smartphone 318 to fully enclose the smartphone 318and become interposed between the smartphone 318 and the guide 100. Inthis manner, the smartphone 318 is not required itself to be sterilizedfor use in the surgical field. Once the sterile cover 3056, whenprovided, is enclosing the smartphone 318 as desired, the guide 100 canbe removably attached to the smartphone 318, as shown in the sequence ofFIGS. 31-32 . To wit, the inclinometer 318 is inserted into theinclinometer-accepting slot 116, and the apparatus 100 is slid laterallyonto the smartphone 318 to any desired position or relationship. It iscontemplated that the apparatus 100 could have a physical limit (e.g., ablind-ended inclinometer-accepting slot 116) to assist with achieving adesired relative relationship with the smartphone 318 serving as theinclinometer. It is also contemplated the smartphone 318 could includesome sort of physical stop or user-perceptible marking to help the userachieve the desired relationship between the apparatus 100 and thesmartphone 318.

Again, as previously noted, the needle guiding aperture 122 (which mayextend substantially perpendicularly to a display of the smartphone 318)defines an actual needle guide trajectory. As shown in FIG. 33 , aneedle 724 is inserted at least partially into a selected needle guidingaperture 122 and thus achieves a position substantially parallel to theactual needle guide trajectory. When the needle guiding aperture 122 isof the “slot” type, the needle 724 may be laterally moved intoengagement with a slot-type needle guiding aperture 122. This may behelpful, for example, when the distal most tip of the needle is insertedvery slightly into the patient tissue 1238 at the insertion location, inorder to “anchor” the needle 724 during movement of the apparatus 100under guidance from the smartphone 318.

As previously described, the smartphone 318 can be placed into a“coarse” relative position with respect to the patient's body by theuser lightly placing the distalmost tip of the needle 724 against thepatient tissue 1238 at the desired insertion location, or by a veryslight (to avoid potential patient tissue damage) insertion of theneedle 724 into the patient tissue 1238. With that tip of the needle 724held in place against the desired insertion location and with the needle724 being in engagement with the apparatus 100, the smartphone 318 canbe precessed or otherwise moved with respect to the patient tissue 1238.This can be considered to be “fine” relative positioning, and is carriedout until the target indicator 1642 indicates that the actual needleguide trajectory is in substantial conformance to the planned needleguide trajectory. At this point, the apparatus 100, and by extension theneedle guiding aperture 122 and associated needle 724, can be consideredto be “dialed in” at the predetermined orientation with respect to thepatient's body, and the needle 724 is “pointing” along the direction andtrajectory at which it should be inserted into the patient tissue 1238.The smartphone 318 is then maintained in such a predeterminedorientation with respect to the patient's body, with the predeterminedorientation being imposed responsive to the planned needle guidetrajectory.

With the smartphone 318 maintained in the predetermined orientation withrespect to the patient's body, the needle 724 is advanced at leastpartially through the needle guiding aperture 122 and into the patient'sbody, as depicted in FIG. 34 . With the smartphone 318, the actualneedle guide trajectory is monitored during advancement of the needle724, and a user receives indication of conformance of the actual needleguide trajectory to the planned needle guide trajectory. It iscontemplated that, during advancement of the needle 724, the needle 724could slightly deviate from the planned needle guide trajectory, and thesmart phone 318 may be configured to provide an audible, visual, haptic,or other user-perceptible indication when the needle 724 starts to leavethe planned trajectory course.

The system may indicate to a user when the needle 724 has achieved apredetermined insertion depth, through a collar 2854 or other depth ofinsertion marking, as previously described. A target indicator 1642could be used in combination with an optical sensor 2444 to assist withconforming the actual needle guide trajectory to the planned needleguide trajectory. Intraoperative imaging could also or instead bepresent to help the apparatus 100 guide the user to carry out apredetermined insertion procedure.

Regardless of the options, configurations, features, operations, andother aspects of the system and apparatus 100 shown and describedherein, however, once the needle 724 has been inserted into the patienttissue 1238 at a desired insertion location and along the planned needleguide trajectory, as well as to a desired insertion depth, the distalmost tip of the needle should be located at or near a subcutaneoustarget site 3558 within the patient tissue 1238, as shown schematicallyin the cross-sectional intraoperative image of FIG. 35 .

Once the needle 724 guidance is no longer desired, the user may removethe apparatus 100 from the needle 724 in any desired manner. Forexample, the apparatus 100 could be longitudinally slid off the proximalend of the needle 724 or, when the needle guiding aperture 122 is of the“slot” type, the apparatus 100 could be moved laterally out ofengagement with the needle 724. The needle 724 can be used to accomplishthe desired task at the target site 3558, and then the needle 724 can bewithdrawn, in any desired manner, from the patient tissue 1238. Theapparatus 100 can be removed from the smartphone 318, and any providedsterile cover 3056 could also be disengage from the smartphone 318. Theapparatus 100 could be discarded or sterilized for reuse, as desired.

It is contemplated that an inclinometer 318 and apparatus 100 could beprovided as a single-piece unit, with the apparatus 100 not intended tobe removed from the inclinometer 318 after completion of themanufacturing process, other than as needed for repair or refurbishment.That is, the user will receive, store, operate, clean, and otherwiseinteract with the inclinometer 318 and apparatus 100 as a single-piecedevice—the apparatus 100 forming a portion of the housing of theinclinometer 318, effectively.

It is also contemplated that a range of apparatuses 100 could beprovided, with each apparatus 100 of the range having different overalldimensions, different configuration and/or dimensions of needle guidingapertures 122, different configurations of handles 120, or any otherdesired differences, in order to create a “library” of apparatuses 100from which a user could select a suitable one for any of a variety ofinsertion guiding tasks.

While aspects of this disclosure have been particularly shown anddescribed with reference to the example aspects above, it will beunderstood by those of ordinary skill in the art that various additionalaspects may be contemplated. For example, the specific methods describedabove for using the apparatus are merely illustrative; one of ordinaryskill in the art could readily determine any number of tools, sequencesof steps, or other means/options for placing the above-describedapparatus, or components thereof, into positions substantively similarto those shown and described herein. In an effort to maintain clarity inthe Figures, certain ones of duplicative components shown have not beenspecifically numbered, but one of ordinary skill in the art willrealize, based upon the components that were numbered, the elementnumbers which should be associated with the unnumbered components; nodifferentiation between similar components is intended or implied solelyby the presence or absence of an element number in the Figures. Any ofthe described structures and components could be integrally formed as asingle unitary or monolithic piece or made up of separatesub-components, with either of these formations involving any suitablestock or bespoke components and/or any suitable material or combinationsof materials; however, the chosen material(s) should be biocompatiblefor many applications. Any of the described structures and componentscould be disposable or reusable as desired for a particular useenvironment. Any component could be provided with a user-perceptiblemarking to indicate a material, configuration, at least one dimension,or the like pertaining to that component, the user-perceptible markingpotentially aiding a user in selecting one component from an array ofsimilar components for a particular use environment. A “predetermined”status may be determined at any time before the structures beingmanipulated actually reach that status, the “predetermination” beingmade as late as immediately before the structure achieves thepredetermined status. The term “substantially” is used herein toindicate a quality that is largely, but not necessarily wholly, thatwhich is specified—a “substantial” quality admits of the potential forsome relatively minor inclusion of a non-quality item. Though certaincomponents described herein are shown as having specific geometricshapes, all structures of this disclosure may have any suitable shapes,sizes, configurations, relative relationships, cross-sectional areas, orany other physical characteristics as desirable for a particularapplication. Any structures or features described with reference to oneaspect or configuration could be provided, singly or in combination withother structures or features, to any other aspect or configuration, asit would be impractical to describe each of the aspects andconfigurations discussed herein as having all of the options discussedwith respect to all of the other aspects and configurations. A device ormethod incorporating any of these features should be understood to fallunder the scope of this disclosure as determined based upon the claimsbelow and any equivalents thereof.

Other aspects, objects, and advantages can be obtained from a study ofthe drawings, the disclosure, and the appended claims.

I claim:
 1. An apparatus for assisting an inclinometer in guiding aneedle into a target location of a patient's body, the inclinometerincluding a planned needle guide trajectory stored in acomputer-readable media readable by the inclinometer, the apparatuscomprising: a top guide surface; a bottom guide surface, longitudinallyspaced from the top guide surface by a guide body; aninclinometer-accepting slot extending laterally into the guide body andlongitudinally spaced from both the top and bottom guide surfaces; atleast one handle extending longitudinally upward from the top guidesurface; and a plurality of needle guiding apertures extending throughthe guide body substantially perpendicularly to the top and bottom guidesurfaces and selectively accepting at least a portion of the needlelongitudinally therethrough, each needle guiding aperture of theplurality of needle guiding apertures having a different largestcross-sectional dimension, measured laterally, than the other needleguiding apertures of the plurality of needle guiding apertures.
 2. Theapparatus of claim 1, wherein the guide body includes a grasping segmenthaving laterally spaced first and second grasping segment ends, thegrasping segment being longitudinally bounded by the top and bottomguide surfaces, and a side arm extending orthogonally and laterally froma selected one of the first and second grasping segment ends, at leastone of the plurality of needle guiding apertures extending through aportion of the guide body forming the side arm.
 3. The apparatus ofclaim 2, wherein the side arm is a first side arm, and the guide bodyincludes a second guide arm extending orthogonally and laterally from another one of the first and second grasping segment ends, the first andsecond guide arms both extending in the same direction from the graspingsegment.
 4. The apparatus of claim 1, wherein at least one of theplurality of needle guiding apertures is a longitudinally extending slotproviding laterally oriented access for the needle thereinto.
 5. Theapparatus of claim 1, including an anesthesia port extending obliquelythrough a portion of the guide body and in fluid communication with atleast one of the plurality of needle guiding apertures at the bottomguide surface.
 6. The apparatus of claim 1, including a device levelerextending longitudinally downward from the guide body, below the bottomguide surface.
 7. The apparatus of claim 1, wherein the inclinometerincludes an optical sensor, the apparatus including a contrast indicatorfor selective engagement with the needle, the contrast indicator beingdetectable with the optical sensor for assisting with guiding the needleinto the target location at the planned needle trajectory.
 8. Theapparatus of claim 1, wherein the inclinometer-accepting slot isconfigured to concurrently contact at least three adjoining orthogonalsides of the inclinometer.
 9. The apparatus of claim 1, wherein theinclinometer-accepting slot extends completely laterally through theguide body.